上海CMC培训 Quality by Design Approach to Formulation and Process Development Case Studies for NDA and ANDA Filings[精品].pptVIP

下载本文档

9
0
约1.17万字
约 35页
2018-04-21 发布于湖北
举报
版权申诉

上海CMC培训 Quality by Design Approach to Formulation and Process Development Case Studies for NDA and ANDA Filings[精品].ppt

1、本文档共35页，可阅读全部内容。
2、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
5、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
6、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
7、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
8、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

上海CMC培训 Quality by Design Approach to Formulation and Process Development Case Studies for NDA and ANDA Filings[精品]

Question Based Review and QbD(Continued) Formulation How was the formulation developed and optimized? Was DoE methodology utilized to determine the critical formulation factors? Manufacturing Process What is the relationship between the properties of the formulation and the optimal manufacturing process? How are the critical process parameters identified and how are they controlled? * Quality of Generic Drugs Approved generic drugs meet high quality standards and are equivalent to their reference products ANDA rejections are weighted equally to ANDA approval in OGD staff evaluations Public recognize the OGD’s contribution to product quality OGD encourages industry to implement QbD 2012 OGD CMC Strategic Goals Lawrence Yu, “Strategic Planning and Question Based Review”, FDA/GPhA QbD Workshop on ANDAs, May 2010 * Risk Assessment Example Vaithiyalingram SR, “QbD IR Example: Process Development”, FDA/GPhA QbD Workshop on ANDA, May 2010. * CPP and Control Strategy Example(Tabletting) Vaithiyalingram SR, “QbD IR Example: Process Development”, FDA/GPhA QbD Workshop on ANDA, May 2010. Input Criticality Control Strategy Ribbon density Critical PAR: 0.68-0.81 Granule PSD Demonstrated Not Critical PAR: 250 – 500 μm Granule uniformity Demonstrated Not Critical PAR: 4% RSD Press Geometry Not Critical Fixed Tooling Geometry Not Critical Fixed Feeder Speed Not Critical PAR: 10-18 rpm Feeder Fill Depth Not Critical PAR: 15-20 mm Pre-Compression Force Demonstrated Not Critical PAR: 0.5-3.0 Kn Controlled based on Ribbon Density Compression Force Critical PAR: 6.8-13.5 Kn Controlled based on Ribbon Density Ejection Force Potentially Critical Fixed: 0.2 kN Press Speed Demonstrated Not Critical PAR: 1000-7000 TPM * More and more companies are applying QbD principle to more and more products Tool and technologies required for QbD are continuously being developed and improving QbD is not just about tool and technologies, it is also about culture and philosophy. The concept